ANDA 076625

MAYNE PHARMA

FDA Drug Application

Application #076625

Documents

• Label: 2012-10-22

Application Sponsors

ANDA 076625

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.02MG;0.1MG

0

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	2004-11-18
LABELING; Labeling	SUPPL	10	AP	2012-07-30
LABELING; Labeling	SUPPL	14	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	10	Null	15
SUPPL	14	Null	15
SUPPL	17	Null	7

TE Codes

001

Prescription

AB1

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76625
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG;0.1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/30\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/076625Orig1s10Lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/076625Orig1s10Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEVONORGESTREL AND ETHINYL ESTRADIOL","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.02MG;0.1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-07-30
        )

)